MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA MISAGO RX SELF-EXPANDING PERIPHERAL STENT

Catalog Number	SXR07150L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was limited to the information provided by the user facility.The production lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.The user facility reported that two stents were placed in the patient, also see mdr 9681834-2016-00208.There is no evidence that this event was related to a device defect or malfunction.A cause-and-effect relationship between this complaint and the actual sample cannot be definitely determined based on the available information.The potential for such an event is addressed in the instruction-for-use (ifu) with statements such as the following: "patients for a peripheral intervention should be selected carefully.Operators should bear in mind that complications, including (but not limited to) subacute thrombosis, vessel complication and hemorrhagic complications, may result from peripheral intervention".Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.H3 other text : actual device not available.
Event or Problem Description
The user facility reported thrombosed stents after they were placed in the patient.Follow up communication with the user facility confirmed the following information: the doctor used two 7x150 misago stents; angiographic result after stent placement showed the stents to be thrombosed; the patient was dripped with tpa overnight and treated several days later with a (b)(6); the patient had surgical intervention for ''compartment syndrome'' related to the ischemia of the leg while major arteries were thrombosed; and a tech at (b)(6) reported that under angiography the stents had restenosed at the edges.

• Brand Name: MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5916968
• Report Number: 9681834-2016-00211
• Device Sequence Number: 915998
• Product Code: NIP
• UDI-Device Identifier: 04987350722263
• UDI-Public: (01)04987350722263
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: SXR07150L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7X150 MISAGO STENT; 7X150 MISAGO STENT
• Outcome Attributed to Adverse Event: Other